Characterization of a thermostable hepatitis B vaccine formulation

• Published in: Vaccine 2009-07, Vol.27 (34), p.4609-4614
• Main Authors: Braun, LaToya Jones, Jezek, Jan, Peterson, Sabrina, Tyagi, Anil, Perkins, Shalimar, Sylvester, David, Guy, Mark, Lal, Manjari, Priddy, Scott, Plzak, Heidi, Kristensen, Debra, Chen, Dexiang
• Format: Article
• Language: English
• Subjects: Allergy and Immunology; Animals; Applied microbiology; Biological and medical sciences; Cold; Drug Stability; Excipients - pharmacology; Female; Formulation; Freezing; Fundamental and applied biological sciences. Psychology; Hepatitis; Hepatitis B; Hepatitis B Antibodies - blood; Hepatitis B vaccine; Hepatitis B Vaccines - adverse effects; Hepatitis B Vaccines - immunology; Hepatitis B Vaccines - radiation effects; Human viral diseases; Immunization; Infectious diseases; Male; Medical sciences; Mice; Mice, Inbred BALB C; Microbiology; Rabbits; Stability; Studies; Temperature; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Viral diseases; Viral hepatitis
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2009.05.069

Abstract Cold chain requirements for vaccine storage and distribution are both economic and logistical burdens for immunization programs, especially those in lower-resource settings. Inadvertent exposure of vaccines to both heat and freezing temperatures within such cold chains are frequently occurring problems in both developing and industrialized countries. Here we report on a new hepatitis B vaccine formulation that is stable against repeated freezing at −20 °C and is also stable for 12 months at 37 °C. The thermostable vaccine contains all the components of the original vaccine plus 7.5% (v/v) propylene glycol, 40 mM phosphate, and 40 mM histidine with a final pH of 5.2. The propylene glycol is responsible for the freeze stability while the other components are essential for the heat stability. This formulation was found to be well tolerated in rabbits without any significant local or systemic side effects. The improved stability of this hepatitis B vaccine could be a key factor in ensuring vaccine effectiveness, extending immunization coverage, simplifying immunization logistics, and reducing the costs associated with the cold chain.